Quality Manager

Kimberly-Clark • Neenah, WI

11d • Onsite

About The Position

The Quality Manager is a key leadership position within a manufacturing facility with accountability to establish and maintain a robust Quality Management System (QMS) compliant with FDA Class 1 and Class 1 Exempt Medical Device requirements and consistently capable of shipping product conforming to the Finished Product Specification (FPS) and other regulatory and customer requirements. This role is key in building talent and quality system capabilities throughout the manufacturing facility aligned with K-C core values of putting quality into everything we do. The plant quality manager drives the culture of quality across the entire site in alignment with the strategic quality plan and supporting the business objectives. This position provides direct leadership to a team of six quality professionals, with responsibility for developing talent, building organizational capability, and driving continuous improvement across quality systems and processes. The role reports through the manufacturing quality organization and maintains a strong dotted-line relationship with the Plant Manager to ensure alignment between quality objectives, operational priorities, and site business goals.

Requirements

• Bachelor’s degree in relevant scientific discipline and typically 7+ years of experience in targeted area.
• Extensive experience in Manufacturing and relevant Quality role required.
• Demonstrated people management experience.
• Working knowledge and experience with products requiring compliance to FDA medical device regulations.
• Experience as a Quality Management Representative in 3rd party and/ or Regulatory audits; Background in managing Medical Device Quality Management Systems, leadership skills in building quality talent throughout a manufacturing facility and have a strong track record of meeting business objectives as a key business partner.

Nice To Haves

• A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer / Manager of Quality Organizational Excellence / Auditor.

Responsibilities

• Develops and deploys the facility quality plan ensuring alignment with the K-C North America Strategic Quality Plan and Supply Chain Strategic Business Plan.
• Ensures adequate resources are available and trained to implement the facility quality plan and required day-to-day activities.
• Engage with and influence the facility management team and other stakeholders such as product development, logistics and suppliers to maintain a focused quality culture within the facility.
• Establishes and maintains the facility QMS, ensuring it is capable of consistently meeting FDA Medical Device requirements for Class 1 and Class 1 Exempt products and other customer requirements.
• Serves as the Quality Management Representative for 3rd party and regulatory audits.
• Leads the Quality Management Review process for the facility and responsible for ensuring actions are assigned and complete.
• Leads the CAPA review board for the facility ensuring all employees associated with CAPA action items have the capabilities and resources to complete their assignments.
• Ensures incoming materials meet raw material specifications with the authority to reject nonconforming raw materials.
• Communicate material issues and partners with suppliers to improve performance through the SCAR (Supplier Corrective Action Request) process as appropriate.
• Ensures the facility process validation system is executed appropriately and maintains compliance to medical device expectations and master validation plans.
• Ensures finished product shipped from the facility conforms to the Finished Product Specification (FPS) and is documented in a device history record.
• Has authority to hold non-conforming or potentially non-conforming product.
• Accountable to manage non-conforming product through the nonconforming material escalation procedures.
• Ensures the on-line asset test equipment and product test laboratory equipment is calibrated and all personnel performing product testing or inspection are qualified.
• Ensures internal audit plans are developed and deployed and builds capability for lead auditors.

Benefits

• medical, dental, and vision coverage options with no waiting periods or pre-existing condition restrictions.
• Access to an on-site fitness center, occupational health nurse, and allowances for high-quality safety equipment.
• Flexible Savings and spending accounts to maximize health care options and stretch dollars when caring for yourself or dependents.
• Diverse income protection insurance options to protect yourself and your family in case of illness, injury, or other unexpected events.
• Additional programs and support to continue your education, adopt a child, relocate, or even find temporary childcare.
• eligibility for a target bonus
• comprehensive benefits suite, including our 401(k) and Profit Sharing plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager